Skip to content

The Value of Myomectomy in Women With Intramural Myoma Before IVF.

The Value of Myomectomy in Women With Intramural Myoma Before IVF. A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03904368
Enrollment
100
Registered
2019-04-05
Start date
2019-04-30
Completion date
2020-12-31
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibroid Uterus, IVF

Brief summary

Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH), , estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.

Detailed description

Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention .The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH), , estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.

Interventions

PROCEDUREOpen myomectomy

laparotomy then enucleation of the myoma followed by closure of the myometrial cavity

Gonadotropin stimulation of follicular growth

DRUGHuman chorionic gonadotropin

HCG triggering of ovulation

PROCEDUREOvum pick up

34 to 36 hours after HCG triggering

PROCEDUREEmbryo transfer

Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* • age younger than 40 years * FSH) less than 10 IU/L * serum prolactin level normal * uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography

Exclusion criteria

* abnormal endocrine function (e.g. abnormal thyroid or adrenal function) * ovarian cysts, * hydrosalpinx * endometrial polyps * male partner with azoospermia * ICSI performed for preimplantation genetic diagnosis.

Design outcomes

Primary

MeasureTime frameDescription
clinical pregnancy rate4 weeks after embryo transferappearance of one or more intrauterine gestational sac by transvaginal ultrasound

Countries

Egypt

Contacts

Primary ContactAhmed Maged, MD
prof.ahmedmaged@gmail.com+201005227404

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026